- Actalent (Gaithersburg, MD)
- …therapy experience + Must be located in EST time zone Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member of ... to agency questions, and maintenance activities. + Coordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams… more
- Amgen (Thousand Oaks, CA)
- …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global CMC ** **What you will do** ... of regulatory experience **Preferred Qualifications:** + Substantial experience leading CMC Regulatory Affairs strategy and execution for biologic products… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Establish collaboration with Takeda teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives on drug-device ... product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC ; international experience is a plus + Experience working… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- Astellas Pharma (Westborough, MA)
- …and/or credibility. **Organizational Context:** Reports to Director or Senior Director , Regulatory Affairs CMC . **Qualifications:** **Required** + BS ... www.astellas.com . This position is based in Westborough, MA. Remote work from certain states may be permitted in...Technology, Quality Assurance, Business Partners). Responsible for developing global CMC regulatory strategy (eg, CMC … more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , CMC Program Lead, Cell Therapies in Cambridge, MA with ... and product quality improvement in Chemistry, Manufacturing & Control ( CMC ) processes; Employ technical project management principles (project planning, RACI,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory guidance ... biologics/vaccines, and/or in the rare disease space. In this role, the Director defines and implements regulatory strategies; works with cross-functional… more
- Takeda Pharmaceuticals (Boston, MA)
- …a network of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and Global ... events. + He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision making and… more
- Merck (Columbus, OH)
- …pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors and ... **Job Description** The Executive Director , Device Quality & Regulatory will...oversight of product validation, verification, and risk mitigation activities. Regulatory CMC Oversight + Lead the preparation… more
- Merck (Columbus, OH)
- …**Reports to** - Director Regulatory Compliance, Device Quality and Regulatory **Location** - Remote , Preference would be to work from Rahway, NJ, ... **Job Description** **Position Title** - Director / Principal Scientist, Regulatory Compliance **Department**...standards. + Provide strategic advice to senior management on CMC regulatory matters based on health authority… more
- Danaher Corporation (Chicago, IL)
- …Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and will be...Affairs located in Fargo, ND and will be fully remote . At Aldevron, we combine best-in-class products and service… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Pharmaceutical Sciences Program Leadership where you will be responsible for ... Sciences Early-Stage Portfolio team, you will report to Pharmaceutical Sciences ( CMC ) Early-Stage Portfolio Leader and mentor and cultivate best practices in… more
- Merck (Rahway, NJ)
- …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
- Merck (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC , formulation functions, and clinical functions to ensure ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
- Actalent (Bridgewater, NJ)
- …activities for cross-functional development projects, including the project management of CMC , clinical and regulatory activities. Manages strategy development, ... Job Title: Director , Clinical Program Management (Generics/New Drug Development) Job...Experience with 505(2)(b) registration pathway + Project management of CMC , clinical and regulatory activities + New… more
- Merck (Columbus, OH)
- …be drivers of innovation and digitalization, as well as thought directors in CMC (Chemistry, Manufacturing and Controls) data analytics to save and improve lives. ... you will do:** You will be an advocate for CMC statistics and data science and serve as a...evaluate data for submissions and assist with replies to regulatory agencies and pharmacopoeia. You will mentor junior members… more
- Bristol Myers Squibb (San Diego, CA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Director Protein Production and Quality Attributes (San Diego, California, USA)** ... part of the Discovery Biotherapeutics team at BMS, the Director of Protein Production and Quality Attributes will play...the global Research organization and beyond (eg, Biologics Drug Product/ CMC teams) to deliver on our biologics pipeline. You… more
- Organon & Co. (Raleigh, NC)
- **Job Description** **The** **Position** **This position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead ... cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project… more
- Bristol Myers Squibb (Seattle, WA)
- …practices and direction for continuous improvement. + Contribute to, review and approve regulatory CMC submissions to ensure their quality and technical content ... personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The Executive Director , Drug Product Process Development is accountable for global network… more